PlainHospital

BAXTER HEALTHCARE PTE. LTD.

Manufacturer adverse-event records for BAXTER HEALTHCARE PTE. LTD. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1996–2015 · heavy-book · typical Death-code · injury-light

Injury-mix signature

BAXTER HEALTHCARE PTE. LTD. is lighter on Injury codes

Injury-coded event_type share is 1.4% (injury-light tercile) beside 0.37% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for BAXTER HEALTHCARE PTE. LTD.

The standout signal for BAXTER HEALTHCARE PTE. LTD. is Injury-mix: 1.4% Injury-coded (injury-light) beside 0.37% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BAXTER HEALTHCARE PTE. LTD. with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 9 device types, led in this extract by Malfunction at 22,276 (98.0% of event_type total). Peak single-year volume reaches 6,375 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

22,737
Total Reports
85
Event-type Death
312
Injury Reports
9
Device Types

Event Types

Malfunction 22,276 (98.0%)
Injury 312 (1.4%)
Death 85 (0.4%)
Other 46 (0.2%)
18 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

22,316 (97.7%)
Life Threatening 136 (0.6%)
Required Intervention 132 (0.6%)
R 99 (0.4%)
Death 74 (0.3%)
Other 58 (0.3%)
Hospitalization 16 (0.1%)
Congenital Anomaly 5 (0.0%)
L 4 (0.0%)
Disability 3 (0.0%)
O 1 (0.0%)

Devices (9)

Device Reports
Pump, Infusion 21,070
Pump, Infusion, Pca 1,198
System, Peritoneal, Automatic Delivery 314
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 91
Set, Administration, Intravascular 55
Pump, Infusion, Elastomeric 3
Hexokinase, Glucose 1
Occluder, Patent Ductus, Arteriosus 1
Set, Administration, For Peritoneal Dialysis, Disposable 1

Yearly Trend

96
1996: 36
97
1997: 299
98
1998: 502
99
1999: 408
00
2000: 274
01
2001: 57
02
2002: 106
03
2003: 5,482
04
2004: 1,326
05
2005: 6,375
06
2006: 2,983
07
2007: 102
08
2008: 3,993
09
2009: 433
10
2010: 359
15
2015: 2

Read our methodology - how this data is sourced, computed, and verified.