PUMP 381 PUMP SET (US)
Report
- Report Number
- 1220648-2026-02938
- Event Type
- Injury
- Date Received
- February 11, 2026
- Date of Event
- December 17, 2025
- Manufacturer
- ABIOMED, INC. - 1220648
- Product Code
- OZD
- UDI-DI
- 00813502012279
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B1 ADDED SELECTION AS IT WAS OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. H6 ADDED MEDICAL DEVICE PROBLEM CODE AND TYPE OF INVESTIGATION CODE AS THEY WERE OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED.
H6 HEALTH EFFECT - IMPACT CODE F1905 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE.
THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY ==> PD-CATHETER (TWIST, BENT, KINKED): THE CAUSE OF THE PRODUCT DAMAGE WAS NOT DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS. MAJOR BLEED: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. UNABLE TO PLACE OR POSITION: THE CAUSE OF THE POSITIONING ISSUE WAS NOT DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT ==> DEVICE LOT : 2002833 DEVICE HISTORY BATCH ==> SUBCOMPONENT LOT : N/A DEVICE HISTORY REVIEW ==> THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.
A4 ADDED PATIENT WEIGHT.
DURING AN ATTEMPT TO IMPLANT AN IMPELLA CP DEVICE FOR CARDIOGENIC SHOCK FOLLOWING ACUTE MYOCARDIAL INFARCTION, THE DEVICE COULD NOT BE ADVANCED PAST THE AORTIC ARCH DUE TO TWISTING AND KINKING. THE DECISION WAS MADE TO REMOVE THE PUMP AND USE A NEW ONE. DURING REMOVAL, BLEEDING OCCURRED AT THE ACCESS SITE. HEMOSTASIS WAS ACHIEVED USING A MATTRESS SUTURE AND FEMORAL COMPRESSION DEVICE (FEMSTOP). THE ISSUE WAS RESOLVED WITHOUT FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362494 | PUMP 381 PUMP SET (US) | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. - 1220648 | PUMP 381 PUMP SET (US) | 2026783741 | 00813502012279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |